CYANOCOBALAMIN - Generic Drug Details

What are the generic sources for cyanocobalamin and what is the scope of patent protection?

Cyanocobalamin is the generic ingredient in fifteen branded drugs marketed by Par Pharm, Pharmacia And Upjohn, Lilly, Watson Labs, Abraxis Pharm, Am Regent, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Luitpold, Lyphomed, Mylan Institutional, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, Sanofi Aventis Us, Sola Pharms, Solopak, Somerset Theraps Llc, Vitruvias Therap, Warner Chilcott, West-ward Pharms Int, Wyeth Ayerst, Xiromed, Zydus Pharms, Accord Hlthcare, Merck, Bel Mar, Bristol Myers Squibb, Savage Labs, Bayer Hlthcare, Lupin, Padagis Israel, Endo Pharms Inc, West Ward, Ge Healthcare, and Armour Pharm, and is included in forty-four NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for cyanocobalamin. Twenty-three suppliers are listed for this compound.

Summary for CYANOCOBALAMIN

US Patents:	6
Tradenames:	15
Applicants:	40
NDAs:	44
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	39
Patent Applications:	3,563
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for CYANOCOBALAMIN
Drug Sales Revenues:	Drug sales revenues for CYANOCOBALAMIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CYANOCOBALAMIN
What excipients (inactive ingredients) are in CYANOCOBALAMIN?	CYANOCOBALAMIN excipients list
DailyMed Link:	CYANOCOBALAMIN at DailyMed

See drug prices for CYANOCOBALAMIN

See drug sales revenues for CYANOCOBALAMIN

Recent Clinical Trials for CYANOCOBALAMIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fundação Educacional Serra dos Órgãos	Phase 4
University of Kansas Medical Center	Phase 2
Tanta University	Phase 3

See all CYANOCOBALAMIN clinical trials

Pharmacology for CYANOCOBALAMIN

Drug Class

Vitamin B12

Anatomical Therapeutic Chemical (ATC) Classes for CYANOCOBALAMIN

B03BA	Vitamin B12 (cyanocobalamin and analogues)
B03B	VITAMIN B12 AND FOLIC ACID
B03	ANTIANEMIC PREPARATIONS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for CYANOCOBALAMIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NASCOBAL	Nasal Spray	cyanocobalamin	500 mcg/spray	021642	1	2017-04-28

US Patents and Regulatory Information for CYANOCOBALAMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	VIBISONE	cyanocobalamin	INJECTABLE;INJECTION	080557-003	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Pharmacia And Upjohn	BERUBIGEN	cyanocobalamin	INJECTABLE;INJECTION	006798-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	083120-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Warner Chilcott	CYANOCOBALAMIN	cyanocobalamin	INJECTABLE;INJECTION	007085-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Endo Pharms Inc	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	AB	RX	Yes	Yes			Y
Bristol Myers Squibb	RUBRAMIN PC	cyanocobalamin	INJECTABLE;INJECTION	006799-010	Apr 28, 1988		DISCN	Yes	No

Expired US Patents for CYANOCOBALAMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Par Pharm	NASCOBAL	cyanocobalamin	GEL, METERED;NASAL	019722-001	Nov 5, 1996
Endo Pharms Inc	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005
Endo Pharms Inc	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005